Rapid, Portable HIV Detection and Monitoring System The long term objectives of this project are: 1. Develop a prototype of a rapid portable instrument for detecting and measuring the amount of Human Immunodeficiency Viruses (HIV's) in samples of patient blood, particularly in low resource settings. 2. Carry out a pilot study to establish the effectiveness and comparative performance of the instrument against an established reference system. The aim is to provide clinicians tools to diagnose and monitor HIV that exist in resource abundant settings but are not readily available in low resource settings. In particular, the instrument system will provide clinicians with detection methods that could be helpful in identifying acute HIV-1, early diagnosis of infection in pregnant women and infants, monitoring viral load following treatment and monitoring for the emergence of antiretroviral resistance. Viral load monitoring of patients on antiretrovirals is a good example of the difference in treatment between resource abundant and low resource settings. Routinely done in the former because of the threat to patients and community should they develop a drug resistant strain of HIV, millions of recipients of antiretroviral therapy currently are not being monitored due to its cost and complexity. These aims are congruent with those parts of the mission of DAIDS "to bring an end to the HIV/AIDS epidemic by supporting the advancement of therapies for HIV infection and its complications...." This project will achieve its stated goals by carrying out a system design of a compact, fast portable system, identifying all the subsystem requirements and required technology advances and then proceeding to tackle them. The researchers at UMass Medical School will develop an effective HIV PCR assay. Thermal Gradient will carry out research on critical aspects of the key PCR amplification device and DNA sample preparation modules, and then will design and demonstrate requisite performance of the integrated test cartridge and system. Arcxis Biotechnologies is expected to contribute key DNA sample preparation technology to the integrated cartridge. Finally, the performance of the system (instrument, cartridge and assay) will be validated, first in internal tests using prepared blood samples and then a significant pilot study. PUBLIC HEALTH RELEVANCE: Rapid, Portable HIV Detection and Monitoring System A rapid HIV POC diagnostic and monitoring device would facilitate diagnosis and monitoring of antiretroviral therapy in resource-limited settings. POC tests can make HIV testing accessible in areas with limited laboratory facilities and can provide immediate test results that are needed to make clinical decisions. In particular, easy-to- use HIV tests could transform the management of pediatric HIV/AIDS in developing countries, averting millions of infant deaths, and help alleviate the threat to public health represented by the current practice of treating millions of HIV patients with antiretrovirals without monitoring their viral loads.